Written Request for temporary waiver of mandatory electronic reporting

MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)

OMB: 0910-0291

IC ID: 233178

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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Written Request for temporary waiver of mandatory electronic reporting
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 329.100(c)(2)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

1 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 1 0 1 0 0 0
Annual IC Time Burden (Hours) 1 0 1 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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